Panels › General, Plastic Surgery › Product code GBO · Class 1
Catheter, Nephrostomy, General & Plastic Surgery
Regulation 878.4200
0510(k)s in 12 months (11 all time)
0recalls in 12 months (8 all time)
2recalls that name a 510(k)
Top companies in GBO
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 0 | 7 |
| Angiomed U.S., Inc. | 5 | 0 |
| Uresil Corp. | 3 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 0 |
| Cook Inc. | 0 | 1 |
| Van-Tec, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2004 | K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY Uresil, LLC | GBO |
| Jun 13, 2002 | K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C Uresil, L.P. | GBO |
| Aug 12, 1991 | K912109 | URESIL GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. | GBO |
| Jan 24, 1986 | K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) Angiomed U.S., Inc. | GBO |
| Jan 24, 1986 | K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS Angiomed U.S., Inc. | GBO |
| Jan 24, 1986 | K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) Angiomed U.S., Inc. | GBO |
| Jan 24, 1986 | K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) Angiomed U.S., Inc. | GBO |
| Jan 24, 1986 | K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) Angiomed U.S., Inc. | GBO |
| Apr 13, 1982 | K820867 | PERCUTANEOUS NEPHROSTOMY SET Van-Tec, Inc. | GBO |
| Jan 22, 1979 | K781664 | SILASTIC NEPHROSTOMY SYSTEM Dow Corning Corp. Healthcare Industries Materials | GBO |
| Sep 20, 1978 | K781526 | SILASTIC U-TUBE KIT Dow Corning Corp. Healthcare Industries Materials | GBO |
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